Effects of PEEP and FIO2 in ALI and ARDS (HELP)

This study has been completed.
Sponsor:
Collaborator:
Asociación Científica Pulmón y Ventilación Mecánica
Information provided by:
Instituto Canario de Investigacion Biomedica
ClinicalTrials.gov Identifier:
NCT00435110
First received: February 12, 2007
Last updated: February 13, 2007
Last verified: February 2006

February 12, 2007
February 13, 2007
May 2004
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00435110 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of PEEP and FIO2 in ALI and ARDS
Effects of PEEP and FiO2 in the Evaluation of Severity of ALI and ARDS

Current American-European Consensus Conference (AECC) definitions for ALI and ARDS are inadequate for inclusion into clinical trials due to the lack of standardization for measuring the oxygenation defect. We questioned whether an early assessment of oxygenation on specific ventilator settings would identify patients with established ARDS (persisting over 24h).

We designed this study to determine whether standard ventilator settings applied on the day ARDS is identified (Day 0) or 24 hours (Day 1) later: (1) would have an impact on the reclassification of patients into ALI or ARDS, and (2) would identify groups with different clinical outcomes. Our hypothesis was that the assessment of PaO2/FiO2 on standard ventilator settings 24 hours after patients originally met the AECC definition of ARDS would identify patients with established ARDS (persisting over 24 h) from others with different degrees of lung injury. If this hypothesis is supported, it would suggest that patients with a better outcome could have been preferentially entered into one group of previously conducted clinical trials, resulting in a viable therapy being proved useless or useless therapy proven viable.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Acute Respiratory Distress Syndrome
  • Acute Lung Injury
  • Acute Respiratory Failure
  • Procedure: standard ventilatory settings
  • Procedure: PEEP and FiO2
Not Provided
Villar J, Perez-Mendez L, Lopez J, Belda J, Blanco J, Saralegui I, Suarez-Sipmann F, Lopez J, Lubillo S, Kacmarek RM; on behalf of the HELP Network. An early PEEP/FIO2 trial identifies different degrees of lung injury in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Oct 15;176(8):795-804. Epub 2007 Jun 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
October 2005
Not Provided

Inclusion Criteria:

  • All patients meeting American-European Consensus Conference (AECC) ARDS criteria were approached for enrollment regardless of their current status or past medical history.

Exclusion Criteria:

  • The only patients excluded were those in which >24 hrs had pasted after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00435110
22
Not Provided
Not Provided
Instituto Canario de Investigacion Biomedica
Asociación Científica Pulmón y Ventilación Mecánica
Principal Investigator: Jesus Villar, MD, PhD Instituto Canario de Investigación Biomédica
Instituto Canario de Investigacion Biomedica
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP